Sailendra Meher Email and Phone Number
Accomplished Biologics Manufacturing Specialist with over 12 years of experience in Drug Substance (DS) process development, technology transfer, and GMP compliance within the biosimilars industry. Proven track record in managing diverse cell-based platforms and driving end-to-end biologics manufacturing processes. Having extensive expertise in the following areas mentioned below :đComprehensive Process Development & Technology Transfer for BiologicsđExpertise in Upstream & Downstream Processing, including Fermentation & PurificationđProficient in Quality Management Systems (QMS), cGMP Compliance, and CAPA InvestigationsđSkilled in Process Validation, Continuous Process Verification (CPV), and Cleaning ValidationđRegulatory Audit Readiness and Inspection HandlingđTechnical Proficiency:SAP S4 HANA PP Module, e-QMS (Trackwise)Data Analytics (JMP), e-LMS, Auto CADComputer System Validation (CSV)
Biosimilar Sciences India Llp
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Manager-Manufacturing And Process Development-Drug SubstanceBiosimilar Sciences India LlpMumbai, Mh, In
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Manager-Process Development, Manufacturing & Gmp ComplianceBiosimilar Sciences India Llp Oct 2022 - PresentMumbai, Maharashtra, India⢠Led end-to-end process development, optimization, and scale-up of biologics DS manufacturing processes.⢠Developed scalable, high-yielding DS processes for Microbial & Mammalian biologics.⢠Managed technology transfer, facility fit assessments, and cGMP compliance for partner sites.
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Deputy Manager -Qms & ComplianceBiocon Biologics Oct 2021 - Sep 2022Bengaluru, Karnataka, India⢠Managed quality records, CAPAs, and change controls to ensure compliance with cGMP standards at Biocon Biologics in Bengaluru, India.⢠Spearheaded initiatives to enhance quality systems and supplier qualification processes, driving operational excellence.⢠Led supplier qualification, developed quality agreements, and executed GMP improvement projects to meet regulatory requirements. -
Deputy ManagerUsv Private Limited Apr 2020 - Sep 2021Mumbai, Maharashtra, India⢠Led manufacturing QMS for Pegfilgrastim DS, ensuring regulatory compliance and readiness for audits.⢠Supervised bulk DS Pegfilgrastim manufacturing for regulated markets, ensuring quality and efficiency.⢠Implemented computer system validation for GXP systems, enhancing digitalization and efficiency. -
Senior ExecutiveUsv Private Limited Apr 2019 - Mar 2020Mumbai, Maharashtra, India
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ExecutiveUsv Private Limited Oct 2015 - Mar 2019Mumbai, Maharashtra, India⢠Led upstream bioprocessing of biopharmaceuticals from E.Coli platform, optimizing processes and validating scale-up/down models.⢠Conducted equipment commissioning/qualification and managed quality systems following regulatory guidelines.⢠Authored technical reports, investigated non-conformances, and ensured equipment/system compliance at USV PRIVATE LIMITED.
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Senior OfficerWockhardt Ltd. Apr 2014 - Sep 2015Aurangabad, Maharashtra, India⢠Managed fermentation of rh-Insulin/Glargine from E Coli and yeast platforms, overseeing sophisticated DCS & SCADA Batch management systems.⢠Led Upstream Processing of production scale up to 20,000L fermenters, including prebatch activities, inoculum development, and parameter monitoring.⢠Played a key role in project implementation at Project C at Wockhardt Biotech Park. -
OfficerWockhardt Ltd. Jun 2013 - Mar 2014Aurangabad, Maharashtra⢠Managed fermentation of rh-Insulin/Glargine from E Coli and yeast platforms, overseeing sophisticated DCS & SCADA Batch management systems.⢠Led Upstream Processing of production scale up to 20,000L fermenters, including prebatch activities, inoculum development, and parameter monitoring.⢠Played a key role in project implementation at Wockhardt Ltd.
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Officer FermentationRossari Biotech Ltd Dec 2011 - May 2013Silvassa⢠Managed submerged fermentation of enzymes using fungal strains at Rossari Biotech Ltd in Silvassa.⢠Oversaw upstream and downstream processing, including inoculum development and batch preparation.⢠Monitored parameters, documented processes, and ensured production fermenter efficiency.⢠Contributed to the successful production of high-quality enzymes for various applications.
Sailendra Meher Education Details
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Manufacturing Management & Analytics
Frequently Asked Questions about Sailendra Meher
What company does Sailendra Meher work for?
Sailendra Meher works for Biosimilar Sciences India Llp
What is Sailendra Meher's role at the current company?
Sailendra Meher's current role is Manager-Manufacturing and Process Development-Drug Substance.
What schools did Sailendra Meher attend?
Sailendra Meher attended Indian Institute Of Management Tiruchirappalli, Biju Patnaik University Of Technology, Odisha.
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